MAUDE Adverse Event Report: SYNTHES HAGENDORF INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Model Number 03.231.005

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/03/2017

Event Type  Injury  

Manufacturer Narrative

Patient gender and weight not available for reporting.Additional product codes: hwc, hrs.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: (b)(4), manufacturing date: 06.May 2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the interlocking bolt for a 4.5 mm variable angle locking compression plate (va-lcp) condylar insertion handle broke intraoperatively during an open reduction internal fixation (orif) of a distal femur on (b)(6) 2017.The handle snapped off and broke on the bottom where the threads meet the base.The thread portion was lodged in the plate and was irretrievable.There was a twenty (20) minute delay in the case because the aiming arm was not able to be used.Patient's outcome was not affected.Concomitant device reported: 4.5 mm va lcp curved condylar plate (part 02.124.413, quantity 1).This report is for one (1) interlocking bolt for 4.5 mm va lcp condylar insertion handle.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant device: plate (part 02.124.414, lot unknown, qty 1).

Manufacturer Narrative

A product investigation was performed.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Visual inspection at customer quality (cq) confirmed the complaint condition.The slightly oblique fracture occurred just proximal to the distal threaded tip.The threaded tip fragment was not returned.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The inside diameter (cannulation) and the outside diameter near location of breakage was measured at cq and found to be within specification per relevant drawing.Unable to determine a definitive root cause.The slightly oblique fracture does suggest an off-axis force was applied thereby causing the breakage.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INTERLOCKING BOLT FOR 4.5MM VA-LCP CONDYLAR INSERTN HANDLE
• Type of Device: IMPLANT,FIXATION DEVICE,CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6888896
• MDR Text Key: 87210842
• Report Number: 3003875359-2017-10475
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077325
• UDI-Public: (01)10886982077325(10)3749207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.005
• Device Catalogue Number: 03.231.005
• Device Lot Number: 3749207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR